Description and Brand Names

US Brand Name

Xyrem

Descriptions

Sodium oxybate is used to treat excessive daytime sleepiness and to reduce the number of cataplexy (weak or paralyzed muscles) attacks in people with narcolepsy. Narcolepsy is an uncontrollable desire for sleep or a sudden attack of deep sleep.

This medicine is available only with your doctor's prescription, and you can only get it from one central pharmacy. Before you use sodium oxybate your doctor should teach you about the safe and effective use of this medicine. You cannot get the medicine until you have read the information the pharmacy will send you about sodium oxybate.

This product is available in the following dosage forms:

Solution

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of sodium oxybate in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies on the relationship of age to the effects of sodium oxybate have not been performed in the geriatric population. However, elderly patients are more likely to have unwanted effects (eg, headache) or age-related liver disease, which may require caution and an adjustment in the dose for patients receiving sodium oxybate.

Pregnancy

Information about this sodium-oxybate-oral-route

Pregnancy Category

Explanation

All Trimesters

C

Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Carbinoxamine

Chloral Hydrate

Diphenhydramine

Doxylamine

Eszopiclone

Ethchlorvynol

Hydroxyzine

Promethazine

Ramelteon

Zaleplon

Zolpidem

Zopiclone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Adinazolam

Alfentanil

Alprazolam

Amobarbital

Anileridine

Aprobarbital

Baclofen

Bromazepam

Brotizolam

Buprenorphine

Buspirone

Butabarbital

Butalbital

Carisoprodol

Chlordiazepoxide

Chlorpromazine

Chlorzoxazone

Clobazam

Clonazepam

Clorazepate

Codeine

Cyclobenzaprine

Dantrolene

Dexmedetomidine

Diazepam

Difenoxin

Diphenoxylate

Divalproex Sodium

Estazolam

Fentanyl

Flunitrazepam

Flurazepam

Fospropofol

Halazepam

Hydrocodone

Hydromorphone

Ketazolam

Levorphanol

Lorazepam

Lormetazepam

Loxapine

Meclizine

Medazepam

Meperidine

Mephenesin

Mephobarbital

Meprobamate

Metaxalone

Methadone

Methocarbamol

Methohexital

Methotrimeprazine

Midazolam

Morphine

Morphine Sulfate Liposome

Nitrazepam

Nordazepam

Orphenadrine

Oxazepam

Oxycodone

Oxymorphone

Pentobarbital

Perampanel

Phenobarbital

Prazepam

Primidone

Propofol

Propoxyphene

Quazepam

Remifentanil

Secobarbital

Sufentanil

Suvorexant

Tapentadol

Temazepam

Thiopental

Thioridazine

Topiramate

Triazolam

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is not recommended. Your doctor may decide not to treat you with this medication, change some of the other medicines you take, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Alcohol abuse, history of or

Drug abuse or dependence, history of—Dependence may be more likely to develop.

Breathing or lung problems (eg, hypopnea or sleep apnea) or

Depression, history of or

Respiratory depression (very slow breathing) or

Suicidal ideation, history of—Use with caution. May make these conditions worse.

Heart failure or

Hypertension (high blood pressure) or

Kidney disease—The amount of sodium in this medicine may make these conditions worse.

Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Succinic semialdehyde dehydrogenase deficiency (rare inborn metabolism disorder)—Should not be used in patients with this condition.

Proper Use

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much is taken, it may become habit-forming. If you think this medicine is not working properly after you have taken it for several weeks, check with your doctor first and do not increase the dose.

It is very important that you understand the requirements of the Xyrem® success program, and become familiar with the Xyrem® Medication Guide and patient instructions. Direct any questions to your doctor or pharmacist before starting treatment.

Take the medicine at least 2 hours after eating. This medicine will make you drowsy very quickly. It is best to take the medicine only at bedtime or when you are ready to fall asleep.

You must first mix each dose with 2 ounces (60 mL) of water. Prepare both doses before bedtime. Place the caps provided on the dosing cups and turn each cap so it locks in its child resistant position. Use the oral liquid within 24 hours after mixing.

Sodium oxybate causes sleep very quickly. Take it only at bedtime and while in bed. Drink all of the first dose while sitting in bed, recap the cup, and then lie down right away. Right before going to sleep place your second dose in a secure place near your bed. You might need to set an alarm to wake up to take the second dose. When you wake up to take the second dose, remove the cap from the second dosing cup. While sitting in bed, drink all of the second dose right before lying down to continue sleeping. Recap the second cup.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (solution):

For treatment of excessive daytime sleepiness and cataplexy:

Adults—2.25 grams (g) given at bedtime and repeated one time during the night. The first dose should be taken at bedtime and the second dose taken 2.5 to 4 hours later. Your doctor may adjust your dose as needed. However, the dose is usually not more than 9 grams per night.

Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss the second dose, skip that dose and do not take any more medicine until the next night. Do not use extra medicine to make up for a missed dose.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Empty any unused medicine down the sink drain, after you have finished using a Xyrem® bottle. Use a marker to cross out the label on the bottle. Then, place the empty bottle in the trash.

Precautions

It is very important that your doctor check your progress at regular visits to make sure the medicine is working properly and to check for any unwanted effects.

Do not use this medicine if you are also taking another sedative or hypnotic medicine (eg, Ambien®, Phenergan®, Seconal®). Also, do not drink alcohol while you are using this medicine. Doing so may increase risk of serious unwanted effects.

It is against the law and dangerous for anyone else to use your medicine. Keep your unused medicine in a safe and secure place. People who are addicted to drugs might want to steal this medicine.

This medicine will add to the effects of other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds, a sleeping medicine, certain medicines for depression or anxiety, prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your medical doctor or dentist before taking any of the above while you are taking this medicine.

This medicine may make you dizzy, drowsy, or less alert than you are normally. Avoid driving, using machines, or doing any activity that could be dangerous if you are not alert for at least 6 hours after taking sodium oxybate.

Do not use more of this medicine or take it more often than your doctor tells you to. This can be life-threatening. Symptoms of an overdose include extreme dizziness or weakness, slow heartbeat or breathing, seizures, trouble breathing, and cold, clammy skin. Call your doctor right away if you notice these symptoms.

This medicine may cause feeling sad or hopeless, change in weight or appetite, loss of interest or pleasure in usual activities, increased tiredness or weakness, or have suicidal thoughts and tendencies. If you notice any of these side effects, call your doctor right away.

Other people living in your house should monitor you for the possibility of urinary or fecal incontinence (loss of bladder or bowel control), or sleepwalking. Tell your doctor if these symptoms occur.

Do not stop using this medicine suddenly without asking your doctor. You may need to slowly decrease your dose before stopping it completely.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Bloating or swelling of the face, arms, hands, lower legs, or feet

rapid weight gain

tingling of the hands or feet

unusual weight gain or loss

Incidence not known

Anxiety

blurred vision

chest pain or discomfort

decrease in the amount of urine

dizziness

fast or pounding heartbeat

fever

headache

hives, itching, or rash

hoarseness

irritation

joint pain, stiffness, or swelling

noisy, rattling breathing

pounding in the ears

redness of the skin

slow heartbeat

sweating

tightness in the chest

troubled breathing at rest

troubled breathing or swallowing

weight gain

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Alternating periods of shallow and deep breathing

bluish lips or skin, not breathing

clumsiness

coma

confusional, agitated combative state

consciousness, depressed

convulsions

drowsiness

generalized slowing of mental and physical activity

inability to hold bowel movement or urine

increased sweating

lightheadedness, dizziness, or fainting

muscle aches or weakness

shakiness and unsteady walk

shivering

sleepiness

slow or irregular heartbeat

trembling or other problems with muscle control or coordination

unusual tiredness or weakness

vomiting

weak or feeble pulse

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

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